MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE-N AUTOGUARD YEL 24GA X .56IN; INTRAVASCULAR CATHETER

Catalog Number 381411

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

Material no.381411, batch no.8002767, 8127853 (unknown which lot had which issue).It was reported that during use of the insyte-n autoguard yel 24 ga x.56 in that the needle bent on one of the insyte and the hub were loose on eight others.The baby received 8 iv pokes before a successful iv start was obtained.Of the 9 insytes that were used, two different lot numbers were used, some from each lot.I do not know from which lot the inyste that bent occurred.With the insyte that bent, it did not break, but bent in an arc like a fencing sword.It did not pierce the skin.The following information was provided by the initial reporter: a new admission baby to nicu for low blood sugar needed an iv start.This baby received 8 iv pokes before a successful iv start was obtained, with a ninth attempt, the insyte needle did not pierce the baby's skin, but the entire needle and cannula bent.The 8 iv pokes had problems due to the hubs of the ivs being loose and sliding on the needle, so it was difficult to advance the needle properly into the vein.Of the 9 insytes that were used, two different lot numbers were used, some from each lot.I do not know from which lot the inyste that bent came.With the insyte that bent, it did not break, but bent in an arc like a fencing sword.It did not pierce the skin.It is this insyte that has been kept for the product inquiry.

Manufacturer Narrative

Additional information: multiple lot numbers: there were multiple lot numbers reported to be involved, but were not confirmed.The information for each lot number is as follows: d.4.Medical device lot #: 8002767; d.4.Medical device expiration date: 12/31/2020; h.4.Device manufacture date: 1/2/2018; d.4.Medical device lot #: 8127853; d.4.Medical device expiration date: 4/30/2021; h.4.Device manufacture date: 5/7/2018.H.6.Investigation summary: the defects introducer defective (loose) and needle penetration difficult; could not be identified or confirmed, and cause could not be determined, as the units described in the product incident report were not returned for evaluation and testing.Examination of the product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of these batches.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

Material no.381411, batch no.8002767, 8127853 (unknown which lot had which issue).It was reported that during use of the insyte-n autoguard yel 24ga x.56in that the needle bent on one of the insyte and the hub were loose on eight others.The baby received 8 iv pokes before a successful iv start was obtained.Of the 9 insytes that were used, two different lot numbers were used, some from each lot.I do not know from which lot the inyste that bent occurred.With the insyte that bent, it did not break, but bent in an arc like a fencing sword.It did not pierce the skin.The following information was provided by the initial reporter: a new admission baby to nicu for low blood sugar needed an iv start.This baby received 8 iv pokes before a successful iv start was obtained, with a ninth attempt, the insyte needle did not pierce the baby's skin, but the entire needle and cannula bent.The 8 iv pokes had problems due to the hubs of the ivs being loose and sliding on the needle, so it was difficult to advance the needle properly into the vein.Of the 9 insytes that were used, two different lot numbers were used, some from each lot.I do not know from which lot the inyste that bent came.With the insyte that bent, it did not break, but bent in an arc like a fencing sword.It did not pierce the skin.It is this insyte that has been kept for the product inquiry.

• Brand Name: INSYTE-N AUTOGUARD YEL 24GA X .56IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8720329
• MDR Text Key: 241261615
• Report Number: 1710034-2019-00646
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814115
• UDI-Public: 30382903814115
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381411
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other